terbutaline sulfate

Generic: terbutaline sulfate

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name terbutaline sulfate
Generic Name terbutaline sulfate
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION
Routes
SUBCUTANEOUS
Active Ingredients

terbutaline sulfate 1 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9746
Product ID 0143-9746_3e8736f7-de5c-4906-851f-6a10a53866ad
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078630
Listing Expiration 2026-12-31
Marketing Start 2009-05-20

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01439746
Hyphenated Format 0143-9746

Supplemental Identifiers

RxCUI
857635
UNII
576PU70Y8E

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name terbutaline sulfate (source: ndc)
Generic Name terbutaline sulfate (source: ndc)
Application Number ANDA078630 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (0143-9746-10) / 1 mL in 1 VIAL (0143-9746-01)
source: ndc

Packages (1)

0143-9746-10 10 VIAL in 1 CARTON (0143-9746-10) / 1 mL in 1 VIAL (0143-9746-01)

Ingredients (1)

terbutaline sulfate (1 mg/mL)

Linked Drug Pages (1)

Terbutaline Sulfate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "3e8736f7-de5c-4906-851f-6a10a53866ad", "openfda": {"unii": ["576PU70Y8E"], "rxcui": ["857635"], "spl_set_id": ["613df3cb-4d55-4d12-ab08-a932481aaa0b"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (0143-9746-10)  / 1 mL in 1 VIAL (0143-9746-01)", "package_ndc": "0143-9746-10", "marketing_start_date": "20090520"}], "brand_name": "Terbutaline Sulfate", "product_id": "0143-9746_3e8736f7-de5c-4906-851f-6a10a53866ad", "dosage_form": "INJECTION", "product_ndc": "0143-9746", "generic_name": "Terbutaline Sulfate", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Terbutaline Sulfate", "active_ingredients": [{"name": "TERBUTALINE SULFATE", "strength": "1 mg/mL"}], "application_number": "ANDA078630", "marketing_category": "ANDA", "marketing_start_date": "20090520", "listing_expiration_date": "20261231"}